Solitaire Ab Stent Sales Aid

Solitaire™ AB - Device selection

Optimal Delivery and Coil Mass Support

Reference Number

Recommended Vessel Size (mm)

Diameter (mm)

Usable Length (mm)

Total Length (mm)

Minimum Microcatheter ID (in.)

Distal Markers

Proximal Markers

SAB-4-15

3.0 – 4.0

4

15

26

0.021

3

1

SAB-4-20

3.0 – 4.0

4

20

31

0.021

3

1

SAB-6-20

5.0 – 6.0

6

20

31

0.027

4

1

SAB-6-30

5.0 – 6.0

6

30

41

0.027

4

1

Fully deployable. * Completely retrievable. Solitaire AB ™

Solitaire™ AB - Detachment box

Total length Usable length

Neurovascular Remodeling Device

Reference Number

Introducer Sheath

NDS-2 Note: It is recommended to use the ev3 Rebar™ Microcatheter for the delivery of Solitaire™ AB.

Rebar™ - Device selection

Push wire Detachment zone Proximal marker

Reference Number

Catheter Class

Usable Length (mm)

ID (in.)

Max Guidewire

Proximal OD

Distal OD

105-5081-153*

18

153

0.021

0.018

2.7F

2.4F

105-5083-153

18

153

0.021

0.018

2.7F

2.4F

105-5082-130

27

130

0.027

0.018

2.8F

2.8F

105-5082-145

27

145

0.027

0.018

2.8F

2.8F

* Dual Marker Band

Distal markers

Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. Not approved for sale in the U.S. Solitaire and Rebar are trademarks of Micro Therapeutics, Inc., d/b/a ev3 Neurovascular. Other names appearing in this document are the property of their respective owners.

Visualization Distal and proximal markers ensure that the exact position of Solitaire AB is always known

ev3 Europe International Headquarters 106-108 rue La Boétie 75008 Paris France PH +33 156 88 59 10 FX +33 156 88 59 11 ev3 Corporate World  Headquarters Peripheral Vascular 9600 54th Avenue North Plymouth, MN 55442-2111 USA PH +1 763 398 7000 FX +1 763 398 7001 www.ev3.net

ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 USA PH +1 949 837 3700 FX +1 949 837 2044 ev3 International Distribution Centre Europalaan 25 6199 AB Maastricht-Airport The Netherlands PH +31 (0) 43 365 9228/9 FX +31 (0) 43 364 6395

ev3 SAS France PH +33 (0) 156 88 31 10 FX +33 (0) 156 88 31 11

ev3 S.r.l Italy PH +39 0267 977 61 FX +39 0266 711 637

ev3 GmbH Germany, Austria PH +49 228 528 830 FX +49 228 528 8360

ev3 B.V. Benelux PH +31 (0) 433 659 223 FX +31 (0) 433 650 283

ev3 Nordic AB PH +46 859 000 950 FX +46 859 000 959

ev3 Ltd. United Kingdom PH +44 1279 659 900 FX +44 1279 654 900

ev3 Technologies  lberica, S.L. Spain PH +34 91 656 7154 FX +34 91 656 7214

*Prior to detachment

Find out more at ev3.net

0297 ©2009 ev3 Inc. All rights reserved.

114612-001 (A) MAR/09

Solitaire™ AB - Device selection

Optimal Delivery and Coil Mass Support

Reference Number

Recommended Vessel Size (mm)

Diameter (mm)

Usable Length (mm)

Total Length (mm)

Minimum Microcatheter ID (in.)

Distal Markers

Proximal Markers

SAB-4-15

3.0 – 4.0

4

15

26

0.021

3

1

SAB-4-20

3.0 – 4.0

4

20

31

0.021

3

1

SAB-6-20

5.0 – 6.0

6

20

31

0.027

4

1

SAB-6-30

5.0 – 6.0

6

30

41

0.027

4

1

Fully deployable. * Completely retrievable. Solitaire AB ™

Solitaire™ AB - Detachment box

Total length Usable length

Neurovascular Remodeling Device

Reference Number

Introducer Sheath

NDS-2 Note: It is recommended to use the ev3 Rebar™ Microcatheter for the delivery of Solitaire™ AB.

Rebar™ - Device selection

Push wire Detachment zone Proximal marker

Reference Number

Catheter Class

Usable Length (mm)

ID (in.)

Max Guidewire

Proximal OD

Distal OD

105-5081-153*

18

153

0.021

0.018

2.7F

2.4F

105-5083-153

18

153

0.021

0.018

2.7F

2.4F

105-5082-130

27

130

0.027

0.018

2.8F

2.8F

105-5082-145

27

145

0.027

0.018

2.8F

2.8F

* Dual Marker Band

Distal markers

Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. Not approved for sale in the U.S. Solitaire and Rebar are trademarks of Micro Therapeutics, Inc., d/b/a ev3 Neurovascular. Other names appearing in this document are the property of their respective owners.

Visualization Distal and proximal markers ensure that the exact position of Solitaire AB is always known

ev3 Europe International Headquarters 106-108 rue La Boétie 75008 Paris France PH +33 156 88 59 10 FX +33 156 88 59 11 ev3 Corporate World  Headquarters Peripheral Vascular 9600 54th Avenue North Plymouth, MN 55442-2111 USA PH +1 763 398 7000 FX +1 763 398 7001 www.ev3.net

ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 USA PH +1 949 837 3700 FX +1 949 837 2044 ev3 International Distribution Centre Europalaan 25 6199 AB Maastricht-Airport The Netherlands PH +31 (0) 43 365 9228/9 FX +31 (0) 43 364 6395

ev3 SAS France PH +33 (0) 156 88 31 10 FX +33 (0) 156 88 31 11

ev3 S.r.l Italy PH +39 0267 977 61 FX +39 0266 711 637

ev3 GmbH Germany, Austria PH +49 228 528 830 FX +49 228 528 8360

ev3 B.V. Benelux PH +31 (0) 433 659 223 FX +31 (0) 433 650 283

ev3 Nordic AB PH +46 859 000 950 FX +46 859 000 959

ev3 Ltd. United Kingdom PH +44 1279 659 900 FX +44 1279 654 900

ev3 Technologies  lberica, S.L. Spain PH +34 91 656 7154 FX +34 91 656 7214

*Prior to detachment

Find out more at ev3.net

0297 ©2009 ev3 Inc. All rights reserved.

114612-001 (A) MAR/09

Clinical successes

Cekirge J Neurosurg 107, 2007

RETRIEVE

RE-DEPLOY

Ease in delivery

Immediate and midterm follow-up results of using an electrodetachable, fully retrievable (SOLO*) stent system in the endovascular coil occlusion of wide-necked cerebral aneurysms

• Only Solitaire AB allows for multiple retrieval, even after full deployment for adjustment and superior placement • Features electrolytic detachment for control of detachment after deployment. Solitaire AB can be detached before or after coil embolization • When not detached, Solitaire AB can be safely held or placed without risk of migration of the stent during coil placement or balloon use

Optimal coil mass support

POST-TREATMENT CONTROL

6 month F/U

A: Initial diagnostic left VA angiogram, demonstrating a ruptured mid-BA wide-necked aneurysm and vasospasm of the BA. B: Nonsubtracted view showing deployed but not detached SOLO* stent in the BA across the aneurysm neck. Three distal radiopaque markers are indicated by arrows. A 4x7 mm HyperForm™ Balloon (arrowheads) was positioned within the stent from the contralateral VA. The aneurysm was then embolized with stent- and balloon-assisted coil insertion, and detachment of the stent was accomplished after endosaccular coil placement. C: Immediate post-treatment angiogram exhibiting complete occlusion of the aneurysm.

Neuroradiology, 2006

.010

C

.008 .006 .004 .002 .000 Neuroform

Cell overlap The Solitaire closed cell design provides optimum scaffolding to prevent coil herniation into the parent artery

A Novel Self-Expanding Fully Retrievable Intracranial Stent (SOLO*): Experience in Nine Procedures of Stent-Assisted Aneurysm Coil Occlusion

195°

153°

73°

Thomas Liebig, Hans Henkes, Jörg Reinartz, Elina Miloslavski, and Dietmar Kühne

• Designed for optimal vessel conformability. Due to its unique self-expanding Nitinol design, Solitaire AB easily adopts to the tortuous path of vessels • Its open slit, closed cell design gives Solitaire AB an optimal radial force with good kink resistance

3

A * SOLO is now Solitaire AB.

B

C

Enterprise

D

Progress of the treatment in patient 1 A, B and pretreatment T2-W transverse MRI scan D. Initially, the aneurysm was selected with a microcatheter for coil delivery A, followed by the deployment of the first of two SOLO* stents and a number of loosely fitting coils B. Finally, another SOLO* stent was placed almost entirely overlapping the first, and the aneurysm was roughly 90% occluded with a total of nine coils C.

D

3.5

Solitaire AB Cell Overlap for various vessel diameters for 4 mm device

.012

.011

.012

LEO

Due to its unique overlap design, Solitaire AB provides excellent wall apposition for stability in the vessel and radial strength to support the coil mass

B

.014

Wall apposition

D: Six-month follow-up angiogram, revealing stable complete occlusion.

A

Liebig, Henkes

Solitaire AB has a radial force that allows for flexibility and optimal coil mass support due to: • Closed cell design • High cell deformation resistance

.008

PRE-TREATMENT 3D RECONSTRUCTION

.016

.006

Proximal Marker

Kivilcim Yavuz, M.D., Serdar Geyik, M.D., Almila Gulsum Pamuk, M.D., Osman Koc, M.D., Isil Saatchi, M.D., and H. Saruhan Cekirge, M.D.

• Designed for single–operator delivery and deployment • Delivery through a standard 0.021” or 0.027” micro catheter on a 0.016” pushwire means Solitaire AB delivers just like a coil

Accuracy and deployment control

Distal Markers

Radial force

Note the difference in terms of vessel diameter that does not favoritize stent opening

Case pictures courtesy of Pr. Moret – Rothschild Foundation, Paris, France

DEPLOY

Coils artefact at neck location

• Lack of kinking • Good conformability • Coverage at the neck

The unique overlap design of Solitaire AB gives flexibility and allows for conformance to the vessel while minimizing straightening of the vessel

.004

LINNC, 2008

• Despite acute angle, Solitaire AB shows minimal narrowing

Radial Force per Unit Length (N/mm)

Solitaire AB Neurovascular Remodeling Device is the only self-expanding stent designed for bridging the neck of aneurysms that can be completely retrieved, even when fully deployed for unmatched procedural control. ™

Flexibility / lumen conformability

• Both distal and proximal sections comply with vessel wall and show nice opening

4.0 mm Solitaire in 3 mm vessel, 2.4 mm bend radius

Moret

The difference is in the design

4.03

Solitaire

Wingspan

Clinical successes

Cekirge J Neurosurg 107, 2007

RETRIEVE

RE-DEPLOY

Ease in delivery

Immediate and midterm follow-up results of using an electrodetachable, fully retrievable (SOLO*) stent system in the endovascular coil occlusion of wide-necked cerebral aneurysms

• Only Solitaire AB allows for multiple retrieval, even after full deployment for adjustment and superior placement • Features electrolytic detachment for control of detachment after deployment. Solitaire AB can be detached before or after coil embolization • When not detached, Solitaire AB can be safely held or placed without risk of migration of the stent during coil placement or balloon use

Optimal coil mass support

POST-TREATMENT CONTROL

6 month F/U

A: Initial diagnostic left VA angiogram, demonstrating a ruptured mid-BA wide-necked aneurysm and vasospasm of the BA. B: Nonsubtracted view showing deployed but not detached SOLO* stent in the BA across the aneurysm neck. Three distal radiopaque markers are indicated by arrows. A 4x7 mm HyperForm™ Balloon (arrowheads) was positioned within the stent from the contralateral VA. The aneurysm was then embolized with stent- and balloon-assisted coil insertion, and detachment of the stent was accomplished after endosaccular coil placement. C: Immediate post-treatment angiogram exhibiting complete occlusion of the aneurysm.

Neuroradiology, 2006

.010

C

.008 .006 .004 .002 .000 Neuroform

Cell overlap The Solitaire closed cell design provides optimum scaffolding to prevent coil herniation into the parent artery

A Novel Self-Expanding Fully Retrievable Intracranial Stent (SOLO*): Experience in Nine Procedures of Stent-Assisted Aneurysm Coil Occlusion

195°

153°

73°

Thomas Liebig, Hans Henkes, Jörg Reinartz, Elina Miloslavski, and Dietmar Kühne

• Designed for optimal vessel conformability. Due to its unique self-expanding Nitinol design, Solitaire AB easily adopts to the tortuous path of vessels • Its open slit, closed cell design gives Solitaire AB an optimal radial force with good kink resistance

3

A * SOLO is now Solitaire AB.

B

C

Enterprise

D

Progress of the treatment in patient 1 A, B and pretreatment T2-W transverse MRI scan D. Initially, the aneurysm was selected with a microcatheter for coil delivery A, followed by the deployment of the first of two SOLO* stents and a number of loosely fitting coils B. Finally, another SOLO* stent was placed almost entirely overlapping the first, and the aneurysm was roughly 90% occluded with a total of nine coils C.

D

3.5

Solitaire AB Cell Overlap for various vessel diameters for 4 mm device

.012

.011

.012

LEO

Due to its unique overlap design, Solitaire AB provides excellent wall apposition for stability in the vessel and radial strength to support the coil mass

B

.014

Wall apposition

D: Six-month follow-up angiogram, revealing stable complete occlusion.

A

Liebig, Henkes

Solitaire AB has a radial force that allows for flexibility and optimal coil mass support due to: • Closed cell design • High cell deformation resistance

.008

PRE-TREATMENT 3D RECONSTRUCTION

.016

.006

Proximal Marker

Kivilcim Yavuz, M.D., Serdar Geyik, M.D., Almila Gulsum Pamuk, M.D., Osman Koc, M.D., Isil Saatchi, M.D., and H. Saruhan Cekirge, M.D.

• Designed for single–operator delivery and deployment • Delivery through a standard 0.021” or 0.027” micro catheter on a 0.016” pushwire means Solitaire AB delivers just like a coil

Accuracy and deployment control

Distal Markers

Radial force

Note the difference in terms of vessel diameter that does not favoritize stent opening

Case pictures courtesy of Pr. Moret – Rothschild Foundation, Paris, France

DEPLOY

Coils artefact at neck location

• Lack of kinking • Good conformability • Coverage at the neck

The unique overlap design of Solitaire AB gives flexibility and allows for conformance to the vessel while minimizing straightening of the vessel

.004

LINNC, 2008

• Despite acute angle, Solitaire AB shows minimal narrowing

Radial Force per Unit Length (N/mm)

Solitaire AB Neurovascular Remodeling Device is the only self-expanding stent designed for bridging the neck of aneurysms that can be completely retrieved, even when fully deployed for unmatched procedural control. ™

Flexibility / lumen conformability

• Both distal and proximal sections comply with vessel wall and show nice opening

4.0 mm Solitaire in 3 mm vessel, 2.4 mm bend radius

Moret

The difference is in the design

4.03

Solitaire

Wingspan

Clinical successes

Cekirge J Neurosurg 107, 2007

RETRIEVE

RE-DEPLOY

Ease in delivery

Immediate and midterm follow-up results of using an electrodetachable, fully retrievable (SOLO*) stent system in the endovascular coil occlusion of wide-necked cerebral aneurysms

• Only Solitaire AB allows for multiple retrieval, even after full deployment for adjustment and superior placement • Features electrolytic detachment for control of detachment after deployment. Solitaire AB can be detached before or after coil embolization • When not detached, Solitaire AB can be safely held or placed without risk of migration of the stent during coil placement or balloon use

Optimal coil mass support

POST-TREATMENT CONTROL

6 month F/U

A: Initial diagnostic left VA angiogram, demonstrating a ruptured mid-BA wide-necked aneurysm and vasospasm of the BA. B: Nonsubtracted view showing deployed but not detached SOLO* stent in the BA across the aneurysm neck. Three distal radiopaque markers are indicated by arrows. A 4x7 mm HyperForm™ Balloon (arrowheads) was positioned within the stent from the contralateral VA. The aneurysm was then embolized with stent- and balloon-assisted coil insertion, and detachment of the stent was accomplished after endosaccular coil placement. C: Immediate post-treatment angiogram exhibiting complete occlusion of the aneurysm.

Neuroradiology, 2006

.010

C

.008 .006 .004 .002 .000 Neuroform

Cell overlap The Solitaire closed cell design provides optimum scaffolding to prevent coil herniation into the parent artery

A Novel Self-Expanding Fully Retrievable Intracranial Stent (SOLO*): Experience in Nine Procedures of Stent-Assisted Aneurysm Coil Occlusion

195°

153°

73°

Thomas Liebig, Hans Henkes, Jörg Reinartz, Elina Miloslavski, and Dietmar Kühne

• Designed for optimal vessel conformability. Due to its unique self-expanding Nitinol design, Solitaire AB easily adopts to the tortuous path of vessels • Its open slit, closed cell design gives Solitaire AB an optimal radial force with good kink resistance

3

A * SOLO is now Solitaire AB.

B

C

Enterprise

D

Progress of the treatment in patient 1 A, B and pretreatment T2-W transverse MRI scan D. Initially, the aneurysm was selected with a microcatheter for coil delivery A, followed by the deployment of the first of two SOLO* stents and a number of loosely fitting coils B. Finally, another SOLO* stent was placed almost entirely overlapping the first, and the aneurysm was roughly 90% occluded with a total of nine coils C.

D

3.5

Solitaire AB Cell Overlap for various vessel diameters for 4 mm device

.012

.011

.012

LEO

Due to its unique overlap design, Solitaire AB provides excellent wall apposition for stability in the vessel and radial strength to support the coil mass

B

.014

Wall apposition

D: Six-month follow-up angiogram, revealing stable complete occlusion.

A

Liebig, Henkes

Solitaire AB has a radial force that allows for flexibility and optimal coil mass support due to: • Closed cell design • High cell deformation resistance

.008

PRE-TREATMENT 3D RECONSTRUCTION

.016

.006

Proximal Marker

Kivilcim Yavuz, M.D., Serdar Geyik, M.D., Almila Gulsum Pamuk, M.D., Osman Koc, M.D., Isil Saatchi, M.D., and H. Saruhan Cekirge, M.D.

• Designed for single–operator delivery and deployment • Delivery through a standard 0.021” or 0.027” micro catheter on a 0.016” pushwire means Solitaire AB delivers just like a coil

Accuracy and deployment control

Distal Markers

Radial force

Note the difference in terms of vessel diameter that does not favoritize stent opening

Case pictures courtesy of Pr. Moret – Rothschild Foundation, Paris, France

DEPLOY

Coils artefact at neck location

• Lack of kinking • Good conformability • Coverage at the neck

The unique overlap design of Solitaire AB gives flexibility and allows for conformance to the vessel while minimizing straightening of the vessel

.004

LINNC, 2008

• Despite acute angle, Solitaire AB shows minimal narrowing

Radial Force per Unit Length (N/mm)

Solitaire AB Neurovascular Remodeling Device is the only self-expanding stent designed for bridging the neck of aneurysms that can be completely retrieved, even when fully deployed for unmatched procedural control. ™

Flexibility / lumen conformability

• Both distal and proximal sections comply with vessel wall and show nice opening

4.0 mm Solitaire in 3 mm vessel, 2.4 mm bend radius

Moret

The difference is in the design

4.03

Solitaire

Wingspan

Solitaire™ AB - Device selection

Optimal Delivery and Coil Mass Support

Reference Number

Recommended Vessel Size (mm)

Diameter (mm)

Usable Length (mm)

Total Length (mm)

Minimum Microcatheter ID (in.)

Distal Markers

Proximal Markers

SAB-4-15

3.0 – 4.0

4

15

26

0.021

3

1

SAB-4-20

3.0 – 4.0

4

20

31

0.021

3

1

SAB-6-20

5.0 – 6.0

6

20

31

0.027

4

1

SAB-6-30

5.0 – 6.0

6

30

41

0.027

4

1

Fully deployable. * Completely retrievable. Solitaire AB ™

Solitaire™ AB - Detachment box

Total length Usable length

Neurovascular Remodeling Device

Reference Number

Introducer Sheath

NDS-2 Note: It is recommended to use the ev3 Rebar™ Microcatheter for the delivery of Solitaire™ AB.

Rebar™ - Device selection

Push wire Detachment zone Proximal marker

Reference Number

Catheter Class

Usable Length (mm)

ID (in.)

Max Guidewire

Proximal OD

Distal OD

105-5081-153*

18

153

0.021

0.018

2.7F

2.4F

105-5083-153

18

153

0.021

0.018

2.7F

2.4F

105-5082-130

27

130

0.027

0.018

2.8F

2.8F

105-5082-145

27

145

0.027

0.018

2.8F

2.8F

* Dual Marker Band

Distal markers

Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Solitaire AB Neurovascular Remodeling Device is designed for the treatment of intracranial neurovascular disease. Not approved for sale in the U.S. Solitaire and Rebar are trademarks of Micro Therapeutics, Inc., d/b/a ev3 Neurovascular. Other names appearing in this document are the property of their respective owners.

Visualization Distal and proximal markers ensure that the exact position of Solitaire AB is always known

ev3 Europe International Headquarters 106-108 rue La Boétie 75008 Paris France PH +33 156 88 59 10 FX +33 156 88 59 11 ev3 Corporate World  Headquarters Peripheral Vascular 9600 54th Avenue North Plymouth, MN 55442-2111 USA PH +1 763 398 7000 FX +1 763 398 7001 www.ev3.net

ev3 Neurovascular 9775 Toledo Way Irvine, CA 92618 USA PH +1 949 837 3700 FX +1 949 837 2044 ev3 International Distribution Centre Europalaan 25 6199 AB Maastricht-Airport The Netherlands PH +31 (0) 43 365 9228/9 FX +31 (0) 43 364 6395

ev3 SAS France PH +33 (0) 156 88 31 10 FX +33 (0) 156 88 31 11

ev3 S.r.l Italy PH +39 0267 977 61 FX +39 0266 711 637

ev3 GmbH Germany, Austria PH +49 228 528 830 FX +49 228 528 8360

ev3 B.V. Benelux PH +31 (0) 433 659 223 FX +31 (0) 433 650 283

ev3 Nordic AB PH +46 859 000 950 FX +46 859 000 959

ev3 Ltd. United Kingdom PH +44 1279 659 900 FX +44 1279 654 900

ev3 Technologies  lberica, S.L. Spain PH +34 91 656 7154 FX +34 91 656 7214

*Prior to detachment

Find out more at ev3.net

0297 ©2009 ev3 Inc. All rights reserved.

114612-001 (A) MAR/09